and Human Services (HHS)
EXPIRED
VIOLENCE AGAINST WOMEN: EVALUATING HEALTH CARE INTERVENTIONS Release Date: February 16, 2000 RFA: HS-00-006 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: March 24, 2000 Application Receipt Date: April 27, 2000 PURPOSE The Agency for Healthcare Research and Quality (AHRQ), formerly known as the Agency for Health Care Policy and Research (AHCPR), invites grant applications to conduct research on the outcomes, effectiveness and cost effectiveness of programs for early identification and treatment of domestic violence against women. The goals of this RFA are to develop new knowledge in the prevention of domestic violence, improve the identification of female patients at risk, and to evaluate outcomes and effectiveness of health care interventions designed to treat domestic violence victims. The AHRQ encourages partnerships between health plans, service providers, researchers, and community-specific programs. The research may encompass important aspects of the health care response to domestic violence including adoption and implementation of protocols and practice guidelines, routine screening for domestic violence, on-site capacity to provide treatment and safety planning, and follow-up of victims. The evaluation is encouraged to follow patients over time and to measure whether the intervention improves the health and safety of victims, predicts or improves health care utilization patterns, prevents or reduces the occurrence of domestic violence, or helps us develop better techniques to detect women at risk. The evaluation may use an experimental or quasi- experimental design and include development and testing of performance measurement tools and outcomes related to domestic violence. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000 . ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private nonprofit organizations, including universities, clinics, units of State and local governments, and eligible agencies of the Federal government. For the purpose of this RFA, AHRQ, by statute, can make grants only to non-profit organizations; however, for-profit organizations may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages investigators who are women, members of minority groups and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the RO1 mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. AHRQ is interested in development of longitudinal studies that will follow patients over time. The initial funding period will be for projects of 3 to 5 years. The anticipated award date is September 29, 2000. This RFA is a one-time solicitation. Future unsolicited applications (new and revised) may be resubmitted to the Agency but will compete with all other investigator-initiated applications and be reviewed according to customary peer review procedures. FUNDS AVAILABLE AHRQ expects to award up to $1 million total costs (direct plus facilities and administrative (F&A) costs) in Fiscal Year (FY) 2000 to support the first year of approximately one to three projects under this RFA. The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHRQ that the awards be equal in size. Although this program is provided for in the financial plans of AHRQ, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. RESEARCH OBJECTIVES Background Domestic violence is defined as a pattern of assaultive and coercive behavior that adults use against their intimate partner. Domestic violence is a public health problem affecting millions of women and their families each year. It is the second leading cause of injuries and death among women of childbearing age (Grisso, 1991) and the leading cause of maternal mortality (Fildes, 1992) in at least two major cities. Domestic violence is prevalent among all racial and ethnic minority groups and is not exclusive to one socio-economic strata. The National Violence Against Women (NVAW) Survey in 1998 revealed that 25 percent of surveyed women said they were raped and/or physically assaulted by an intimate partner in their life (Tjaden,1998). The Survey estimated approximately 1.5 million women are raped or physically assaulted by an intimate partner annually in the United States. Approximately one-third of the victims sustain an injury. Further, in about one-third of all such injury victimizations, the victim receives some type of medical care. Domestic violence is a powerful predictor of increased health care utilization. (Bergman et al, 1991; Koss and Koss, 1991; Felitti, 1991). Domestic violence has physical and emotional consequences for victims and their children. The consequences include acute injuries as well as chronic injury, chronic stress and fear, and lack of control over health care or support systems (Chalk and King, 1998). These consequences are manifested in a range of medical, obstetric, gynecological, and mental health problems. Direct health care costs to victims of domestic violence is estimated to be in the range of 1.8 billion dollars per year (Miller et al, 1993). One large health plan showed victims of intimate partner violence against women cost approximately 92 percent more than a random sample of general female enrollees (Wisner et al, 1999). The health care system encounters the consequences of domestic violence in everyday clinical practice. Current efforts of domestic violence interventions in health care have generated standards of care and major initiatives to increase provider awareness, establish and distribute clinical guidelines and to offer strategies for improving institutional responses to domestic violence (Wisner et al, 1999). Comprehensive innovative intervention programs in health care are increasing in number. In 1995, the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) expanded its guidelines on emergency departments and hospital- sponsored ambulatory care centers to encourage the development of staff education and protocols for the acute management of domestic violence (Oakbrook, 1998). In 1998, the Institute of Medicine published a report on Violence in Families: Assessing Prevention and Treatment Programs (Chalk et al, 1998). The report characterized what is known about intervention efforts and developed guiding principles for the development of future evaluations of family violence interventions. The report concluded that scientific research does not provide clear guidance for determining the comparative effectiveness of specific efforts to prevent or treat family violence. Given the important role health care systems can play in identifying patients at risk, preventing recurrences, and responding to the needs of domestic violence victims, the opportunity to evaluate the effectiveness of these interventions is critical. Important aspects of the health care response to domestic violence include institutional adoption and implementation of model protocols and practice guidelines, routine screening for domestic violence, and on-site capacity to provide safety assessment and planning, medical documentation, identification of community resources, assessment and treatment of medical and mental health problems and appropriate follow-up. AHRQ is interested in understanding the key components of effective identification and intervention programs in health care systems. AHRQ is also interested in development of longitudinal studies that will fully assess the impact of the intervention programs with immediate and long-term outcomes, multiple time periods, both self-report and observational measures, and different levels of outcomes. A combination of quantitative and qualitative data measuring the impact of domestic violence intervention strategies could be included. Core questions of greatest interest are: 1) Assessment of effectiveness: Does the intervention improve a woman=s health and safety and sense of safety? Does the intervention improve detection of women at risk? Does the intervention prevent or reduce the recurrence of domestic violence? Does the effectiveness of the intervention vary by subgroup (racial or ethnic background, socioeconomic status, or community of residence e.g., inner-city and rural areas)? 2) Assessment of health care utilization and cost: Does the intervention predict or improve health care utilization patterns? Does the type or cost of services used by victims change following treatment interventions? Is the intervention cost-effective? (Types of analysis which are sought include cost analyses distinguishing between direct and indirect service costs of the program on the health care services used by victims of abuse; the impact of domestic violence on the use of physical, mental, and social services by victims; cost implications for the core health care programs; the costs and benefits associated with integrated service records and more comprehensive record management, especially in managed care settings; the extent to which episodes and histories of violence can be tracked). Related areas also of interest include: 3) Assessing improvement in provider behavior: Has provider behavior, knowledge, and attitude improved? Has the number of eligible women screened, identified, and receiving interventions increased? Has the documentation and case management improved? To what extent is provider behavior influenced by patient characteristics including race or ethnicity, socioeconomic status or community of residence (e.g., inner-city and rural areas)? 4) Assessment of community linkages: Has the intervention improved linkages between individual health services, social support networks, community resources, and more comprehensive prevention efforts? What linkages between screening efforts and treatment work best? Research Methods The studies are encouraged to have an experimental or quasi-experimental longitudinal design, including measurable outcomes and a comparison group. Study design must include provisions for following the use of health care services for abuse victims for a period of at least 3 years, and a plan to establish capacity to follow victims over a longer period of time. SPECIAL REQUIREMENTS Applicants are expected to develop collaborative partnerships between academic researchers, health plans and service providers, and community specific programs responding to domestic violence, with each partner contributing to the substantive operation of the proposal. The nature of the partnership, including the contribution of each and financial agreements shall be explained. If the grantee is a health care system that is proposing to establish referral linkages with domestic violence or social service providers in the community, then both programmatic and financial reimbursement provisions shall be clearly outlined. If more than one project is funded, it is AHRQ=s expectation that projects will use common measures to increase the usefulness of study findings. All funded grantees will be expected to work together to discuss common data elements and measures to the maximum extent feasible. To this end, the investigators will have an initial meeting and subsequent annual one-day meetings convened by AHRQ in Rockville, MD. All applicants should include annual travel costs for one researcher in the budget allowance. Evidence of Satisfactory Progress While it is the intent of AHRQ to fund applications for the maximum period applied for, after two years, the grantee may undergo an external peer review to provide evidence of satisfactory progress for funding beyond a three year period. Interim progress measures may include progress in accrual of sufficient numbers of domestic violence victims necessary to proceed with a valid study; development of record-keeping systems that protect patient safety and confidentiality while providing research data on the types and extent of abuse suffered by the patient, and on the cost and use of physical and mental health care services over time. Data Privacy Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a- 1(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the use and purposes of the data collection. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these standards to subcontractors and vendors should be addressed as necessary. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the Agency=s grants regulations at 42 CFR 67, Subpart A. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a Federal government license to use and permit others to use these products and materials for AHRQ purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant- supported products. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ=s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO=s website http://www.access.gpo.gov/nara/cfr/index.html). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHRQ that women and members of minority groups be included in all AHRQ- supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. In addition to these populations, AHRQ is also interested in supporting research that includes other priority populations, e.g., rural, inner-city, or elderly. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 and in the NIH Guide for Grants and Contracts of March 18, 1994 . To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ contractor, listed under INQUIRIES, or from the NIH Guide Website http://grants.nih.gov/grants/guide/index.html. AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHRQ Website http://www.ahrq.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by March 24, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review consideration of any subsequent application, the information allows AHRQ staff to estimate the potential review workload and avoid conflict of interest in the review. AHRQ will not provide responses to letters of intent. The Letter of Intent is to be sent to Charlotte A. Mullican, M.P.H. (see address under INQUIRIES) APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: [email protected]. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should both indicate RFA number. The RFA label must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must also be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Applicants are encouraged to read all PHS Form 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non- compliant applications returned. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled AAdvanced Copy (s)@ must also be sent to: Charlotte A. Mullican, M.P.H. Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 336 Rockville, MD 20852 Telephone: (301) 594-0382 FAX: (301) 594-3211 Email: [email protected] Applications must be received by April 27, 2000. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of- mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. Application Preparation (for Using HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with the Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. To avoid double counting, applicants should not include the cost of the data in the budget. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with standards set out in OMB Circular A-130, Appendix IIIBSecurity of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. See the Data Privacy section for details on these requirements as well as references to Circular A-130 and its implementation guides from the National Institute of Standards and Technology. In developing research plans, applicants should allow time for refining, approving, and processing their data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their provider require the approval of the HCFA Administrator and may require meeting(s) with HCFA staff. HCFA data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding HCFA data should be directed to the AHRQ program official listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, AHRQ Referral staff may contact the applicant to determine whether to return the application to the applicant or hold it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by AHRQ in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The criteria to be used in the evaluation of grant applications are listed below. The goals of AHRQ-supported research are to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Is the project (or work plan) well organized? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human subjects; and the safety of the research environment. The review group will also examine the extent of the collaborative partnerships developed between academic researchers, community-specific programs, health plans and service providers. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review; 2) availability of funds; 3) program balance with respect to types of health care insurance and organizational delivery system features, enrollee versus community studies, populations studied, geography including rural/urban mix, regional representation, and targeting understudied areas with unmet evaluation needs; 4) compatibility with other awardees with respect to cooperative activities; and 5) policy relevance. INQUIRIES Copies of the RFA are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800- 358-9295 The RFA is also available on AHRQ=s Web site, http://www.ahrq.gov, and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ, please call (301) 594-6344. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations should be directed to: Charlotte A. Mullican, M.P.H. Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 336 Rockville, MD 20852 Telephone: (301) 594-0382 FAX: (301) 594-3211 Email: [email protected] Direct inquiries regarding fiscal and eligibility matters to: Joan Metcalfe Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1841 FAX: (301) 594-3210 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Bergman B, Brismar B, 1991. A 5-year Follow-up Study of 117 Battered Women, American Journal of Public Health, 81 (11):1486-1489. Chalk R, King PA editors, 1998. Health Care Interventions (Chapter 6); Violence in Families: Assessing Prevention and Treatment Programs; National Research Council and Institute of Medicine, 223-224. Felitti VJ, 1991. Long-Term Consequences of Incest, Rape and Molestation. Southern Medical Journal, 84:328-331. Fildes J, Reed L, Jones N, Martin M, Barrett J, 1992. Trauma: The Leading Cause of Maternal Death. J. Trauma, 32:643. Grisso JA, Wishner AR, Schwarz DF, Weene BA, 1991. A Population-Based Study of Injuries in Inner-City Women. Am J Epidemiol, 134:59. Koss MP, Koss PG, Woodruff WJ, 1991. Deleterious Effects of Criminal Victimization on Women=s Health and Medical Utilization. Archives of Internal Medicine, 151:342-347. Miller TR, Cohen MA, Rossman SB, 1993. Victim costs of violent crime and resulting injuries. Health Affairs, 12:186. Oakbrook IL, 1998. Joint Commission on Accreditation Manual for Hospitals: The Official Handbook. Tjaden P, Thoennes N, 1998. Prevalence, Incidence, and Consequences of Violence Against Women: Findings From the National Violence Against Women Survey; National Institute of Justice/Center for Disease Control Research in Brief. November. Wisner CL, Gilmer TP, Saltzman LE, Zink TM, 1999. Intimate Partner Violence Against Women: Do Victims Cost Health Plans More? Journal of Family Practice, 48:439-443.
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